FDA.reportPublic FDA data

Proximal Tool

Primary DI
00878953003023
Brand
Proximal Tool
Company
AMERICAN MEDICAL SYSTEMS, INC.
Model
72404120
Device description
Proximal Cylinder Insertion Tool
Published
2014-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHWDevice, Impotence, Mechanical/Hydraulic
JCWProsthesis, Penis, Inflatable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHWDevice, Impotence, Mechanical/HydraulicGastroenterology, Urology3
JCWProsthesis, Penis, InflatableGastroenterology, Urology3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00878953003023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00878953003023008789530030238789530030230878953003023

GMDN Terms#

Term, Definition table
TermDefinition
Penile prosthesis implantation instrumentA sterile, hand-held manual surgical instrument intended to be used to implant a penile prosthesis (e.g., penile prosthesis cylinder insertion within the corpora cavernosa). It may also be used during revision surgery of a penile prosthesis; it has no general surgical application. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125111448
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00878953005249Spectra 720056-022016-08-12
00878953005201Spectra 720054-012016-08-12
00878953005218Spectra 720054-022016-08-12
00878953005225Spectra 720054-032016-08-12
00878953005232Spectra 720056-012016-08-12
00878953005256Spectra 720056-032016-08-12
00878953005270Spectra 720074-012016-08-12
00878953005287Spectra 720074-022016-08-12
00878953005294Spectra 720074-032016-08-12
00878953005393Spectra RTE Kit720170-012016-08-12
00878953005409Spectra RTE Kit720171-012016-08-12
00878953000602AMS 800 Artificial Urinary Sphincter724000222014-09-24
00878953000640AMS 800 Artificial Urinary Sphincter724000262014-09-24
00878953000657AMS 800 Artificial Urinary Sphincter724000272014-09-24
00878953005881AdVance 844143792016-07-22
00878953005898AdVance 10083802016-07-22
00878953005300AdVance 720088-012016-07-22
00878953000497Sizer720153-012016-09-24
00878953000503Sizer720153-012016-09-24
00878953001036AMS 800 Artificial Urinary Sphincter724016852014-09-24

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Primary DI, Brand, Company table
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05708932768115Titan ClassicColoplast A/SFHW2024-10-29
05708932768139Titan ClassicColoplast A/SFHW2024-10-29
05708932768153Titan TouchColoplast A/SFHW2024-10-29
05708932768177Titan TouchColoplast A/SFHW2024-10-29
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